Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Perfect Fit 3D Effort Module, Abdomen, NOX-T3
DYMEDIX DIAGNOSTICS, INC.
11-45009-0001
In Commercial Distribution

  • 00817377021831 ()


  • Polysomnograph
Perfect Fit™ 3D REUSABLE-Disposable Kit includes: 2- Perfect Fit™3-D sensors, 5-50 yard rolls of Effort Belt Strap, Keyhole
DYMEDIX DIAGNOSTICS, INC.
18-13206-0001
In Commercial Distribution

  • 00817377021824 ()


  • Polysomnograph
Perfect Fit™ 3D Effort Belt Sensor, Abdomen, Nomad
DYMEDIX DIAGNOSTICS, INC.
11-45008-0001
In Commercial Distribution

  • 00817377021817 ()


  • Polysomnograph
Perfect Fit™ 3D Effort Belt Sensor, Chest, Nomad
DYMEDIX DIAGNOSTICS, INC.
11-45008-0002
In Commercial Distribution

  • 00817377021800 ()


  • Polysomnograph
Perfect Fit™ 3D Effort Belt Sensor, Chest, Keyhole
DYMEDIX DIAGNOSTICS, INC.
11-45006-0002
In Commercial Distribution

  • 00817377021794 ()


  • Polysomnograph
Perfect Fit™ 3D Effort Belt Sensor, Abdomen, Keyhole
DYMEDIX DIAGNOSTICS, INC.
11-45006-0001
In Commercial Distribution

  • 00817377021787 ()


  • Polysomnograph
Cadwell Sensor Kit, Adult, Disposable
DYMEDIX DIAGNOSTICS, INC.
18-14240-0602
In Commercial Distribution

  • 00817377021725 ()


  • Polysomnograph
Cadwell ApneaTrak Adult Effort Belt Kit: 2 sensors, 2 ea-45", 60" Straps
DYMEDIX DIAGNOSTICS, INC.
18-14230-0602
In Commercial Distribution

  • 00817377021718 ()


  • Polysomnograph
Perfect Fit™ II R/S Adult Kit includes: 2- Perfect Fit™ II R/S sensors, 2-45” Effort Belt Straps, 2-60” Effort Belt Straps, and 2- R/S Interface Cables, Alice 6
DYMEDIX DIAGNOSTICS, INC.
18-14216-0602
In Commercial Distribution

  • 00817377021701 ()


  • Polysomnograph
Perfect Fit™ II R/S Adult Kit includes: 2- Perfect Fit™ II R/S sensors, 2-45” Effort Belt Straps, 2-60” Effort Belt Straps, and 2- R/S Interface Cables, Grael
DYMEDIX DIAGNOSTICS, INC.
18-14215-0602
In Commercial Distribution

  • 00817377021695 ()


  • Polysomnograph
Perfect Fit™ II R/S Adult Kit includes: 2- Perfect Fit™ II R/S sensors, 2-45” Effort Belt Straps, 2-60” Effort Belt Straps, and 2- R/S Interface Cables, Embla, 1.5 mm
DYMEDIX DIAGNOSTICS, INC.
18-14214-0602
In Commercial Distribution

  • 00817377021688 ()


  • Polysomnograph
Perfect Fit™ II R/S Adult Kit includes: 2- Perfect Fit™ II R/S sensors, 2-45” Effort Belt Straps, 2-60” Effort Belt Straps, and 2- R/S Interface Cables, Embla
DYMEDIX DIAGNOSTICS, INC.
18-14213-0602
In Commercial Distribution

  • 00817377021671 ()


  • Polysomnograph
Perfect Fit ™II Adult Effort Belt Kit: 2 Sensors, 2-ea 45" & 60" Straps, Alice® 3
DYMEDIX DIAGNOSTICS, INC.
18-14212-0602
In Commercial Distribution

  • 00817377021664 ()


  • Polysomnograph
Perfect Fit ™II Adult Effort Belt Kit: 2 Sensors, 2-ea 45" & 60" Straps, Alice® 5
DYMEDIX DIAGNOSTICS, INC.
18-14211-0602
In Commercial Distribution

  • 00817377021657 ()


  • Polysomnograph
Perfect Fit™ II Adult Effort Belt Kit: 2 Sensors, 2-ea 45" & 60" Straps
DYMEDIX DIAGNOSTICS, INC.
18-14210-0602
In Commercial Distribution

  • 00817377021640 ()


  • Polysomnograph
Perfect Fit Adult Effort Belt Kit: 2 sensors, 2 straps (45"), EFM, Alice 5
DYMEDIX DIAGNOSTICS, INC.
18-14204-0602
In Commercial Distribution

  • 00817377021633 ()


  • Polysomnograph
Perfect Fit SUM Adult Effort Belt Kit: 2 sensors, 2 straps (45"), Sum EFM, Alice 5
DYMEDIX DIAGNOSTICS, INC.
18-14203-0602
In Commercial Distribution

  • 00817377021626 ()


  • Polysomnograph
Perfect Fit Adult Effort Belt Kit: 2 sensors, 2 straps (45"), EFM
DYMEDIX DIAGNOSTICS, INC.
18-14202-0602
In Commercial Distribution

  • 00817377021619 ()


  • Polysomnograph
Perfect Fit™SUM Adult Effort Belt Kit: 2 sensors, 2 straps (45"), Sum Interface Cable
DYMEDIX DIAGNOSTICS, INC.
18-14201-0602
In Commercial Distribution

  • 00817377021602 ()


  • Polysomnograph
Perfect Fit™ 3D REUSABLE-Disposable Kit includes: 2- Perfect Fit™3-D sensors, 5-50 yard rolls of Effort Belt Strap, Grael
DYMEDIX DIAGNOSTICS, INC.
18-13205-0001
In Commercial Distribution

  • 00817377021596 ()


  • Polysomnograph
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